Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery

Wound Infection Clinical Trial

Official title:

Prevena™ Incision Management System Versus Dermabond in the Prevention of Groin Wound Infections in Patients Undergoing Vascular Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836990
• Other study ID #: Prevena
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: September 2019

Study information

• Verified date: December 2020
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision Management System versus Dermabond in preventing groin wound infections in patients who undergo vascular surgery requiring a groin wound. Half of the patients will receive Dermabond and the other half will receive the Prevena Incision Management System for their groin wounds.

Description:

Dermabond and the Prevena Incision Management System are both FDA approved wound care products. Prevena is a negative pressure system which holds the wound together and removes exudate and debris from the site to prevent infection. Dermabond is a surgical glue which holds the wound together to prevents infection. Prevena is more expensive to apply. However, the hypothesis is that the Prevena System will decrease infection rates and therefore, decrease the ultimate cost of the health care needed after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. In need of elective vascular procedure requiring =8 cm groin incision.

2. Able to provide consent

3. Able to care for wound or have support person to complete wound care

4. Willing to comply with follow-up

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Wound Infection
• Wounds and Injuries

Intervention

Device:
• Prevena Incision Management System
A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections
• Dermabond
A surgical skin adhesive used to prevent surgical wound infections

Locations

Country	Name	City	State
United States	Kaleida Health, Gates Vascular Institute	Buffalo	New York
United States	State University of New York at Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	KCI USA, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (14)

Bandyk DF. Vascular surgical site infection: risk factors and preventive measures. Semin Vasc Surg. 2008 Sep;21(3):119-23. doi: 10.1053/j.semvascsurg.2008.05.008. Review. — View Citation

Bruns TB, Worthington JM. Using tissue adhesive for wound repair: a practical guide to dermabond. Am Fam Physician. 2000 Mar 1;61(5):1383-8. Review. — View Citation

de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23. — View Citation

Dosluoglu HH, Loghmanee C, Lall P, Cherr GS, Harris LM, Dryjski ML. Management of early (<30 day) vascular groin infections using vacuum-assisted closure alone without muscle flap coverage in a consecutive patient series. J Vasc Surg. 2010 May;51(5):1160-6. doi: 10.1016/j.jvs.2009.11.053. Epub 2010 Mar 31. — View Citation

Easterlin B, Bromberg W, Linscott J. A Novel Technique of Vacuum-assisted Wound Closure That Functions as a Delayed Primary Closure. Wounds. 2007 Dec;19(12):331-3. — View Citation

Engin C, Posacioglu H, Ayik F, Apaydin AZ. Management of vascular infection in the groin. Tex Heart Inst J. 2005;32(4):529-34. — View Citation

Exton RJ, Galland RB. Major groin complications following the use of synthetic grafts. Eur J Vasc Endovasc Surg. 2007 Aug;34(2):188-90. Epub 2007 May 18. — View Citation

Lawlor DK, Derose G, Harris KA, Lovell MB, Novick TV, Forbes TL. The role of platelet-rich plasma in inguinal wound healing in vascular surgery patients. Vasc Endovascular Surg. 2011 Apr;45(3):241-5. doi: 10.1177/1538574411399157. — View Citation

Lee ES, Santilli SM, Olson MM, Kuskowski MA, Lee JT. Wound infection after infrainguinal bypass operations: multivariate analysis of putative risk factors. Surg Infect (Larchmt). 2000 Winter;1(4):257-63. — View Citation

Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. — View Citation

Matatov T, Reddy KN, Doucet LD, Zhao CX, Zhang WW. Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients. J Vasc Surg. 2013 Mar;57(3):791-5. doi: 10.1016/j.jvs.2012.09.037. Epub 2013 Jan 9. — View Citation

Ploeg AJ, Lardenoye JW, Peeters MP, Hamming JF, Breslau PJ. Wound complications at the groin after peripheral arterial surgery sparing the lymphatic tissue: a double-blind randomized clinical trial. Am J Surg. 2009 Jun;197(6):747-51. doi: 10.1016/j.amjsurg.2008.04.014. Epub 2008 Oct 17. — View Citation

Swinnen J, Chao A, Tiwari A, Crozier J, Vicaretti M, Fletcher J. Vertical or transverse incisions for access to the femoral artery: a randomized control study. Ann Vasc Surg. 2010 Apr;24(3):336-41. doi: 10.1016/j.avsg.2009.07.020. Epub 2009 Dec 4. — View Citation

Weir G. The use of a surgical incision management system on vascular surgery incisions: a pilot study. Int Wound J. 2014 Jun;11 Suppl 1:10-2. doi: 10.1111/iwj.12261. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond	The primary effectiveness endpoint is 30 day healing of the randomized groin incision, with any wound infection or failure to heal. Szilagyi wound infection grade quantified on an ordinal scale will be used to assess the healing (None, Grade I: Infection contained to the dermis, Grade II: Infection extending into the subcutaneous tissue but the arterial graft is not involved, Grade III: Infection of the arterial graft or native vessel underlying the incision).; Healing is assessed by complete sealing of the incision with no residual separation or drainage. All of the incisions were primarily closed, so a healed incision would have no gaps between the skin edges. This is a visual inspection.; Szilagi is an assessment of the grade of wound infection for those that did not heal. It is well recognized and published, and noted as above for patients with vascular exposure.	30 days
Secondary	Cost of Care	Comparison of cost of treatment between the two arms	30 days
Secondary	Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection	Physician office visits for diagnosis of Infection or visiting nurse visits for diagnosis of infection ONLY were assessed.	30 days

External Links

•   Prevena TM Incision Management System